CRED SPC

CRED LCM Sep

eCTD

Globalisation of Pharmaceutical Regulation – What do Agencies Discuss behind Closed Doors?

In this session, the US FDA, the EMA, the EU National Health Authorities and
the Japanese Health Authority procedures for sharing information will be
presented. A panel discussion with session speakers and invited guest(s)
will offer the opportunity to explore the topic more fully.

Speakers

  • Yoshikazu Hayashi – International Liaison Officer responsible for EU relations, PMDA, Japan
  • Hilde Boone – European Medicines Agency Liaison Official at the US FDA
  • Janice Soreth – US FDA Liaison at EMA

University innovation celebrated as short-lists are announced for 2010 Regulatory Affairs Awards

The Organisation for Professionals in Regulatory Affairs (TOPRA) is pleased to include the University of Leeds among its short-listed candidates for the 2010 Regulatory Affairs Awards. The Awards are the first in Europe to celebrate the achievements of professionals involved in the regulation of the healthcare industry. Candidates selected for this year’s short-lists reflect the diversity of individuals and organisations that contribute to the development and delivery of safe, effective medical therapies.

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